Class II — Ivoclar Vivadent, Inc.
| Recalling firm | IVOCLAR VIVADENT |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
| Product | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material |
| Quantity | US: 4659 units, Canada: 729 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada and Australia |
| Initiated | 2016-11-09 |
| Classified | 2016-12-07 |
| Terminated | 2018-06-18 |
| Recall number | Z-0717-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ivoclar Vivadent, Inc. (Z-0717-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75620/
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